high purity type i collagen based skin substitute vs dehydrated human amnion/chorion membrane in treatment of dfus

Conditions: Diabetic Foot Ulcer (DFU)

Summary: this is a randomized controlled clinical investigation in patients suffering from diabetic foot ulcers. the study intends to compare patient outcome data using standard of care with type-i collagen-based skin substitute and standard of care with dehydrated human amnion/chorion membrane.

the purpose of this randomized controlled clinical study is to collect and compare patient outcome data at 4 weeks using type-i collagen-based skin substitute in one half of the patients and dehydrated human amnion/chorion membrane in the other half.

Eligibility criteria:
inclusion criteria: * subjects must be at least 18 years of age or older. * subjects must have a diagnosis of type 1 or 2 diabetes mellitus. * at randomization subjects must have a target diabetic foot ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 10.0 cm2 measured post debridement using a ruler to measure wound area. * the target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care prior to the initial screening visit. * the target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus. * the target ulcer must be full thickness on the foot or ankle that does not probe to bone. * adequate circulation to the affected foot as documented by any of the following methods performed within 3 months of the first screening visit: * transcutaneous oxygen measurement (tcom) ≥30 mmhg * ankle-brachial index (abi) between 0.7 and 1.3 * peripheral vascular resistance (pvr): biphasic * toe-brachial index (tbi) ˃0.6 * as an alternative, arterial doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle of the target extremity. * if the subject has two or more ulcers, they must be separated by at least 2 cm. the largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer. * the subject must consent to using the prescribed off-loading method for the duration of the study. * the subject must agree to attend the twice-weekly/weekly study visits required by the protocol. * the subject must be willing and able to participate in the informed consent process. * patients must have read and signed the irb approved icf before screening procedures are undertaken. exclusion criteria: * a subject known to have a life expectancy of \<6 months. * if the target ulcer is infected or if there is cellulitis in the surrounding skin. * presence of osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence. * a subject that has an infection in the target ulcer that requires systemic antibiotic therapy. * a subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy. * topical application of steroids to the ulcer surface within one month of initial screening. * a subject with a previous partial amputation on the affected foot is excluded if the resulting deformity impedes proper offloading of the target ulcer. * a subject with a glycated hemoglobin (hba1c) greater than or equal to 13% taken at or within 3 months of the initial screening visit. * a subject with a serum creatinine ≥ 3.0mg/dl within 6 months of the initial screening visit. o a subject with an acute charcot foot, or an inactive charcot foot, that impedes proper offloading of the target ulcer. * women who are pregnant or considering becoming pregnant within the next 6 months. * a subject with end stage renal disease requiring dialysis. * a subject who participated in a clinical trial involving treatment with an investigational product within the previous 30 days. * a subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments. * a subject treated with hyperbaric oxygen therapy or a cellular and/or tissue product (ctp) in the 30 days prior to the initial screening visit.